A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes

Overview

The purpose of this study is to assess changes in exposure to selected harmful and potentially harmful substances related to tobacco/nicotine use when adult smokers switch from their usual brand of combustible cigarettes to the myblu e-cigarette, for up to 56 days. This study is designed as an open-label, partially-randomized, parallel-arm, multi-site study in healthy adult smokers. Some subjects will be selected to take part in additional procedures as part of a pharmacokinetics (PK) sub-study.

Full Title of Study: “An Open-label, Parallel Study to Assess Tobacco-related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-day Switch to Myblu E-cigarettes in Adult Smokers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Detailed Description

Subjects are randomized to either continue smoking conventional cigarettes, or switch to use the myblu e-cigarette. Within the "myblu" arm, subjects were assigned to one of four variants of the myblu e-cigarette, having different flavors and nicotine strengths. Initial product assignment for each subject was based on preference as a method to enhance compliance. To further improve compliance through Day 56, subjects may have been allowed to choose to switch to another variant of the myblu e-cigarette, or to continue using the same e-liquid selected initially.

Interventions

  • Other: Continue-smoking
    • Ad-libitum use of subjects’ usual brand combustible cigarette
  • Other: myblu Tobacco 2.5%
    • Ad-libitum use of myblu e-cigarette with Tobacco flavor 2.5% nicotine
  • Other: myblu Tobacco 4.0%
    • Ad-libitum use of myblu e-cigarette with Tobacco flavor 4.0% nicotine
  • Other: myblu Honeymoon 2.5%
    • Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine
  • Other: myblu Honeymoon 4.0%
    • Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine
  • Other: JUUL 5%
    • Ad-libitum use of JUUL 5% e-cigarette

Arms, Groups and Cohorts

  • Active Comparator: Continue-smoking
    • The subject’s usual brand of combustible cigarette
  • Experimental: myblu Tobacco 2.5%
    • myblu e-cigarette system with Tobacco flavor, 2.5% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.
  • Experimental: myblu Tobacco 4.0%
    • myblu e-cigarette system with Tobacco flavor, 4.0% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.
  • Experimental: myblu Honeymoon 2.5%
    • myblu e-cigarette system with Honeymoon flavor, 2.5% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.
  • Experimental: myblu Honeymoon 4.0%
    • myblu e-cigarette system with Honeymoon flavor, 4.0% nicotine. At Day 28 of the study, subjects may be allowed to switch to another myblu variant.
  • Active Comparator: JUUL 5%
    • JUUL® system with Virginia Tobacco Flavor JUULpod, 5.0% nicotine. This arm is only included in the PK sub-study.

Clinical Trial Outcome Measures

Primary Measures

  • Concentration of Carboxyhemoglobin in Blood
    • Time Frame: Baseline and 56 days
    • Change from baseline in the % saturation of carboxyhemoglobin (COHb) in whole blood
  • Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
    • Time Frame: Baseline and 56 days
    • Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL – a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) excreted in urine in 24-hours
  • Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
    • Time Frame: Baseline and 56 days
    • Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA – a biomarker of exposure to acrolein) excreted in urine in 24-hours
  • Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours
    • Time Frame: Baseline and 56 days
    • Change from baseline in the amount of s-phenyl mercapturic acid (S-PMA – a biomarker of exposure to benzene) excreted in urine in 24-hours

Secondary Measures

  • Amount of Nicotine Equivalents in Urine in 24 Hours
    • Time Frame: Baseline and 56 days
    • The change from baseline in the amount of nicotine equivalents excreted in urine in 24-hours
  • Level of White Blood Cells
    • Time Frame: Baseline and 56 days
    • The change from baseline in the level of white blood cells, which is a biomarker of potential harm
  • Subjective Measure: Nicotine Withdrawal Symptoms Total Score
    • Time Frame: 56 days
    • Nicotine withdrawal symptoms are measured using the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R) questionnaire. The DSM-5 and craving items from the MTWS-R have been included. The subjects rate themselves on the questionnaire, which includes symptoms such as angry, irritable, frustrated, depressed mood, restless, insomnia. Each question is rated from 0 (none) to 4 (severe). Total scores may range from 0 to a maximum of 32.
  • Maximum Nicotine Concentration in Blood
    • Time Frame: 5 minutes prior, and at 3, 5, 7, 10, 12, 15, 20, 30, 60, 120 and 180 minutes post dose
    • The maximum nicotine concentration in blood (Cmax)

Participating in This Clinical Trial

Inclusion Criteria

  • Having smoked ≥5 manufactured combustible cigarettes per day for at least one year – Exhaled carbon monoxide level of >10 ppm at screening – Tested positive for urinary cotinine (approximately 200 ng/mL) at screening Exclusion Criteria:

  • Relevant illness history – Relevant medication use – Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2 – Allergy to propylene glycol or glycerin – Use of nicotine-containing products other than manufactured cigarettes – Use of prescription smoking cessation treatments – Smokers who draw smoke into their mouth and throat but do not inhale – Intent or desire to stop smoking – Female subjects who are pregnant, lactating, or intend to become pregnant

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fontem Ventures BV
  • Provider of Information About this Clinical Study
    • Sponsor

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